Clearance Summary
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545) received FDA 510(k) clearance under submission number K970126, sponsored by Bio-Rad Laboratories, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1997-02-25.
- Submission: K970126
- Applicant / Sponsor: Bio-Rad Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1260
- Decision date: 1997-02-25
Classification & Regulation
This clearance is catalogued under FDA product code CHP and 21 CFR 862.1260, within the Clinical Chemistry review panel as a Class I device.